Soft tissue repair prosthesis, expandable device, and method of soft tissue repair

ABSTRACT

A hernia repair device is provided which may include a soft tissue repair prosthesis and an expandable device configured to be removably connected with the soft tissue repair prosthesis. When expanded, the expandable device may be configured to position the soft tissue repair prosthesis adjacent a hernia defect. The soft tissue repair prosthesis may include at least one loop or slit configured to receive a portion of the expandable device. The prosthesis may include a tether to hoist, locate or position the soft tissue repair prosthesis. The expandable device may include indicia for positioning the prosthesis relative to the edge of the hernia defect.

FIELD OF INVENTION

The present invention is directed to a soft tissue repair prosthesis, anexpandable device, and to a method of soft tissue repair.

BACKGROUND OF INVENTION

One technique for repairing a soft tissue defect, such as an abdominalwall hernia, involves inserting an implantable prosthesis, such as amesh patch or plug, into an intra-abdominal space, positioning theprosthesis relative to the wall defect, and then, if desired, securingthe prosthesis with tacks, sutures, and/or adhesives.

To deliver the prosthesis intra-abdominally, the prosthesis may berolled up, folded or otherwise collapsed into a reduced profile and theninserted through a small incision or a trocar and into theintra-abdominal space. The prosthesis is then unfurled and positionedrelative to the defect.

SUMMARY OF INVENTION

In one illustrative embodiment, a hernia repair device is provided whichincludes a soft tissue repair prosthesis and at least one loop extendingfrom the prosthesis. The at least one loop has a predetermined sizeconfigured to receive a portion of an expandable device to removablyconnect the prosthesis with the expandable device.

In another illustrative embodiment, a hernia repair device is providedwhich includes a soft tissue repair prosthesis having at least one slittherethrough, where the at least one slit has a predetermined sizeconfigured to receive a portion of an expandable device to removablyconnect the prosthesis with the expandable device.

In yet another illustrative embodiment, a hernia repair device isprovided which includes a soft tissue repair prosthesis having a firstside and a second side, and at least one attachment component coupled tothe prosthesis and extending outwardly from the first side of theprosthesis. The attachment component is configured to receive a portionof an expandable device to removably connect the prosthesis with theexpandable device. The hernia repair device further includes a tethercoupled to the prosthesis and extending outwardly from the second sideof the prosthesis, where manipulation of the tether allows hoisting,locating and/or positioning of the soft tissue repair prosthesis.

In yet a further illustrative embodiment, a hernia repair device isprovided which includes an expandable device configured to be removablyconnected with a soft tissue repair prosthesis, where the expandabledevice includes indicia for referencing a predetermined location forpositioning an edge of a hernia defect relative to the prosthesis suchthat the prosthesis overlaps the edge of the defect a predetermineddistance.

In another illustrative embodiment, a method of delivering a soft tissuerepair prosthesis is provided. The method includes removably connectingat least one loop of a soft tissue repair prosthesis with a portion ofan expandable device, and expanding the expandable device.

In another illustrative embodiment, a method of delivering a soft tissuerepair prosthesis is provided. The method includes removably connectingat least one slit of a soft tissue repair prosthesis with an expandabledevice by inserting a portion of the expandable device into the at leastone slit, and expanding the expandable device.

In yet another illustrative embodiment, a method of repairing a herniadefect is provided. The method includes removably connecting at leastone attachment component coupled to a first side of a soft tissue repairprosthesis with an expandable device to removably connect the softtissue repair prosthesis with the expandable device, inserting theprosthesis and the expandable device into an abdominal space, expandingthe expandable device, and manipulating a tether coupled to a secondside of the soft tissue repair prosthesis to hoist, locate or positionthe soft tissue repair prosthesis.

In a further illustrative embodiment, a method of repairing a herniadefect is provided. The method includes inserting a soft tissue repairprosthesis and an expandable device into an abdominal space where theexpandable device is removably connected to the soft tissue repairprosthesis and wherein the expandable device includes indiciareferencing a predetermined location, expanding the expandable device,and positioning the prosthesis around a hernia defect in an abdominalwall by positioning an edge of the hernia defect at the indiciareferencing the predetermined location such that the prosthesis overlapsthe edge of the defect a predetermined distance.

Various embodiments of the present invention provide certain advantages.Not all embodiments of the invention share the same advantages and thosethat do may not share them under all circumstances.

Further features and advantages of the present invention, as well as thestructure of various embodiments that incorporate aspects of theinvention are described in detail below with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following drawings, wherein likereference characters designate like features, in which:

FIG. 1 is a perspective view of an expandable device and soft tissuerepair prosthesis according to one embodiment of the present invention;

FIG. 2 is a perspective view of the soft tissue repair prosthesis shownin FIG. 1;

FIG. 3 is a top view of the expandable device shown in FIG. 1;

FIG. 4 is a perspective view of an expandable device and soft tissuerepair prosthesis according to another embodiment of the presentinvention;

FIG. 5 is a perspective view of the soft tissue repair prosthesis shownin FIG. 4;

FIG. 6 is a top view of the expandable device shown in FIG. 4;

FIG. 7 is a top view of an expandable device according to anotherembodiment;

FIG. 8 is a detailed view of a portion of an expandable device accordingto one embodiment;

FIG. 9 is a top view of an expandable device according to anotherembodiment;

FIG. 10 is a bottom view of an expandable device and soft tissue repairprosthesis according to one embodiment of the present invention;

FIG. 11 is a perspective view of an expandable device and prosthesisaccording to yet another embodiment of the present invention;

FIG. 12 is a top view of an expandable device according to oneembodiment; and

FIG. 13 is a partial view of an expandable device and soft tissue repairprosthesis according to another embodiment.

DETAILED DESCRIPTION

Aspects of the present invention are directed to a soft tissue repairprosthesis, such as a patch, plug, or patch and plug combination, forrepairing, augmenting or reconstructing a muscle or tissue wall, such asa chest wall or abdominal wall, and that has particular application forrepairing a hernia defect and for reconstruction of the chest wall. Anexpandable device may be provided for delivering, locating and/orpositioning the soft tissue repair prosthesis at the surgical site. Thesoft tissue repair prosthesis may be carried by, tethered to, orotherwise operatively connected with the expandable device, such thatmanipulation of the expandable device will effect the shape, locationand/or positioning of the soft tissue repair prosthesis. The expandabledevice may have a reduced configuration suitable for introduction to thesurgical site and an expanded configuration for deploying, locatingand/or positioning the soft tissue repair prosthesis. Expansion of theexpandable device, when carrying or otherwise integrated with the softtissue repair prosthesis, may cause the soft tissue repair prosthesis totransform from a reduced delivery profile to an enlarged shape suitablefor the desired procedure, such as extending over, under, or filling ahernia defect. The expandable device may be in the form of a balloon orother inflatable bladder, or other construction suitable for delivery ina reduced profile and expansion to a larger size. The soft tissue repairprosthesis may be mounted to, or otherwise integrated with, theexpandable device, and then the combined components may be reduced insize, such as by rolling, folding, or otherwise collapsing, and theninserting through a trocar or small incision into the abdominal cavityor other surgical site. Expansion of the expandable device, such as byinflation where the expandable device is in the form of a balloon, willin turn cause the soft tissue repair prosthesis to move into an expandedconfiguration suitable for the intended procedure. For example, wherethe soft tissue repair prosthesis is a mesh sheet and has been rolled upwith an associated balloon, inflation of the balloon will cause the meshsheet to unroll or otherwise expand into an enlarged shape which canthen be positioned relative to the defect.

Aspects of the present invention are directed to arrangements foroperatively connecting an expandable device with a soft tissue repairprosthesis. In one embodiment, the expandable device and soft tissuerepair prosthesis are detachably connected. For example, and withoutlimitation, one or more loops or other attachment features mayreleasably connect the expandable device and soft tissue repairprosthesis. The loops may loosely connect the components together in thereduced profile, or the loops may not contribute to attachment of theexpandable device and soft tissue repair prosthesis until one or both ofthe expandable device and soft tissue repair prosthesis are in anexpanded configuration.

Other aspects of the present invention are directed to variousapproaches to hoist, locate, center or position the prosthesis relativeto the defect, and yet further aspects of the present invention aredirected to indicia on the expandable device for positioning theprosthesis relative to the hernia defect.

Turning to FIGS. 1-3, the expandable device has a plurality of outwardlyextending arms 12. In this embodiment, the expandable device 10 isshaped like a starfish. As discussed in greater detail below, it shouldbe appreciated that the expandable device may be shaped differently inother embodiments. For example, it is contemplated that the expandabledevice may be circular, rectangular, lattice shaped or irregular shapedas the invention is not so limited.

As shown in FIG. 3, the expandable device 10 may have an open centerportion 14. The open portion may minimize the size or bulk of theexpandable device when the expandable device 10 is rolled or folded intoa reduced profile configuration. This may assist with the insertion ofthe expandable device 10, such as through a small incision or a trocar.In one embodiment, the expandable device is asymmetric about the axiswhich the expandable device is folded or rolled. In this respect,overlap of the arms 12 of the expandable device 10 is minimized if notavoided, reducing the overall profile of the collapsed expandabledevice. Smaller profiles may be desired to facilitate or permit use withnarrow trocar diameters and small incisions.

As shown in FIGS. 1 and 3, an inflation port 20 is positioned on the endof a radially extending arm 12 of the expandable device. As set forthbelow, in another embodiment, the inflation port 20 may extend from adifferent location of the expandable device, and may for example extendfrom a center portion of the expandable device 10. An inflation tube 22runs to the inflation port 20. The inflation tube 22 may be detachablysecured to the inflation port 20 so that the tube 22 can be removedafter inflation. The inflation tube 22 may pass through a trocar (notshown) to outside of the patient for connection to an inflation source,such as a syringe. The invention is not limited to a particularinflation medium. A gas, such as air, may be employed, as may be aliquid, such as saline. Other suitable mediums will be apparent to oneof skill in the art. Further, the expandable device is not limited toinflatable configurations and other arrangements that have a slenderconfiguration suitable for delivery and an expanded configuration fordeployment, locating and/or positioning of the soft tissue repairprosthesis are contemplated.

The expandable device 10 may be removably connected with the soft tissuerepair prosthesis 30 by one or more attachment components, including,but not limited to sutures, adhesives, or mechanical fasteners includinghook and loop fasteners, rivets, and the like. For example, in oneembodiment, an adhesive may be used to detachably connect the prosthesis30 and the expandable device 10. It is contemplated that a sugaradhesive may be used that dissolves when wetted.

In one embodiment, the attachment component is at least one loop 40extending from the prosthesis 30. The loop may have a variable size or,instead, have a predetermined size compatible for securing with aportion of the expandable device. For example, the loop may be sized toconnectably receive a portion of the expandable device when it reachesan expanded configuration. The loops may define an opening that closelyfits around the connecting portion of the expandable device only in theexpanded configuration, or the loops may closely fit around theconnecting portion in both the reduced profile and expandedconfiguration. The loops may be compliant or non-compliant, and the loopopening may expand in response to expansion of the expandable device.For example, as illustrated in FIGS. 1 and 2, a plurality of loops 40may extend from the soft tissue repair prosthesis 30 and one or morearms 12 of the expandable device 10 may extend into the loops 40,removably connecting the expandable device with the soft tissue repairprosthesis. In this respect, the loops may be similar to a belt loop andportions of the expandable device may be configured to fit in the loops.These loops may be formed of a resorbable or a non-resorbable material,as the invention is not limited in this respect. It should beappreciated that the loops 40 may be secured to the prosthesis as shownin FIG. 2 and thereafter secured to the expandable device. It is alsocontemplated that the loops 40 may initially be wrapped around theexpandable device and thereafter secured to the prosthesis as theinvention is not so limited. It also is contemplated that the one ormore loops might be formed on the expandable device with complementaryattachment arrangements being provided on the soft tissue repairprosthesis.

It should be appreciated that the size of the loop 40 is based upon thesize of the portion of the expandable device 10 that would be receivedwithin the loop 40. In one embodiment, the loop has a diameter ofapproximately 2 cm to approximately 10 cm. In another embodiment, theloop has a diameter of at least approximately 5 cm. One of skill in theart would recognize that the loop 40 may be sized to be slightly largerthan the expandable device to accommodate the expandable device 10within the loop 40.

In the particular embodiment illustrated in FIGS. 1 and 2, the loops 40are spaced apart and discretely formed. As illustrated, each loop mayterminate in a knot or weld that prevents the loop 40 from detachingfrom the prosthesis 30. As discussed in greater detail below, in anotherembodiment, the loops 40 are part of an integral structure, such as arunning suture.

It should be appreciated that the loops 40 may be formed from a varietyof materials, as the invention is not limited in this respect. In oneembodiment the loops 40 are formed from suture material, such as but notlimited to polyglycolic acid (PGA), or Vicryl® which is a polyglactinabsorbable suture material. In another embodiment, the loops 40 areformed from soft tissue repair fabric, such as, but not limited toexpanded polytetrafluorethylene (ePTFE). The loops may be configured toencourage tissue infiltration, to resist tissue infiltration, or toprovide localized and differing tissue infiltration properties. Forexample, and without limitation, the loops may be formed of a barriermaterial, include a barrier material, and/or include a coating orsurface treatment that discourages, or encourages, tissue ingrowth.

It should also be recognized that the expandable device 10 may also beformed from a variety of materials, as the invention is not limited inthis respect. In one embodiment, the expandable device is formed ofpolyurethane, and may, for example, be formed of nylon coatedpolyurethane. In an embodiment where the expandable device 10 isinflatable, the expandable device may be formed of two layers of nyloncoated polyurethane that together form a chamber for the introduction ofair.

As illustrated in FIGS. 1 and 2, a tether 50 may be coupled to the softtissue repair prosthesis 30 to assist in hoisting, locating and/orpositioning the soft tissue repair prosthesis, and the expandable deviceif it still is connected therewith. As shown, in one embodiment, thesoft tissue repair prosthesis has a first side and a second side whereat least one attachment component (such as the loops 40) extend from thefirst side of the prosthesis and the tether 50 extends from the secondside of the prosthesis. The tether 50 may be formed from a suture, softtissue repair fabric, or other material as should be apparent to one ofskill in the art. The tether may be resorbable or permanent. The tethermay be singular or include a plurality of tether segments, for examplethe tether 50 may include a plurality of sutures or strips that arespaced about the prosthesis. The tether 50 may be secured approximatelyat the center of the prosthesis 30, or surrounding the center of theprosthesis, such that the center of the prosthesis can more readily bealigned with the center of the hernia defect. However, as should beapparent to one of skill in the art, the invention is not limited to atether that focuses forces at or about the center of the soft tissuerepair prosthesis. With the soft tissue repair prosthesis deployed andexpanded in the intra-abdominal space, a suture-grasping device (notshown) may be provided to grasp the tether and hoist the prosthesis 30towards the defect and/or to position the soft tissue repair prosthesisagainst the abdominal wall. As shown, in one embodiment, the tether 50includes a loop 52 adapted for grasping and manipulation by a surgicalinstrument or the physician's hands. Once the soft tissue repairprosthesis 30 is positioned relative to the defect, sutures, fasteners,adhesives or the like may be applied to fixate the prosthesis 30 inplace.

After placement of the prosthesis 30, the loops 40 may be left in placeor, instead, removed. As an example, and without limitation, aninstrument may be employed to cut the loops. It may be desirable toseparate the soft tissue repair prosthesis from the expandable deviceprior to removing the loops. The soft tissue repair prosthesis may beseparable from an expanded expandable device and, in certainembodiments, it may facilitate separation by at least partially reducingthe size of the expandable device (e.g., such as by at least partiallydeflating where the expandable device is a balloon). As mentioned above,it is also contemplated that the loops 40 are resorbable.

It is also contemplated that in one embodiment, one or more of the loops40 may be used as transfacial sutures to secure the prosthesis 30 aroundthe defect. In other words, the expandable device 10 may be detachedfrom the prosthesis 30 without cutting and/or removing some or all ofthe loops 40. Such loops 40 themselves, or cut into strands, may then beused to secure the prosthesis. It also is contemplated that sutures,distinct from the tether, may be pre-attached to the soft tissue repairprosthesis and used to secure the implant relative to the defect.

A method of repairing a hernia defect in accordance with the presentinvention includes one or more of the steps of: detachably securing anexpandable device to a prosthesis, rolling or folding the prosthesis anddetachably secured expandable device into a slender configuration,inserting the prosthesis and expandable device into theintra-intra-abdominal space, inflating the expandable device to unfurlthe mesh, pulling on a tether coupled to the prosthesis to hoist theprosthesis up against the abdominal wall, fixating the prosthesisagainst the abdominal wall, detaching the expandable device from theprosthesis, and removing the expandable device from theintra-intra-abdominal space.

One method of delivering a soft tissue repair prosthesis includesremovably connecting at least one loop of a soft tissue repairprosthesis with a portion of an expandable device, and expanding theexpandable device. The method may also include inserting the prosthesisand the expandable device into an abdominal space, positioning theprosthesis around a hernia defect in an abdominal wall, securing theprosthesis to the abdominal wall, and detaching the prosthesis and theexpandable device.

Another method of repairing a hernia defect includes removablyconnecting at least one attachment component coupled to a first side ofa soft tissue repair prosthesis with an expandable device to removablyconnect the soft tissue repair prosthesis with the expandable device,inserting the prosthesis and the expandable device into an abdominalspace, expanding the expandable device, and manipulating a tethercoupled to a second side of the soft tissue repair prosthesis to hoist,locate or position the soft tissue repair prosthesis. The method mayfurther include securing the prosthesis to the abdominal wall, anddetaching the prosthesis and the at least one attachment component.

The prosthesis 30 may be formed of a porous material, such as a knit,woven or non-woven fabric, or may be composed of a solid, substantiallynon-porous, or micro-porous material. The prosthesis may be formed ofone or more layers of the same or dissimilar material. The prosthesismay be formed with portions that are tissue infiltratable and otherportions that are non-tissue infiltratable, providing selected areas ofthe repair device with different tissue ingrowth and adhesion resistantproperties. The prosthesis may be formed of permanent material,resorbable material, or a combination of permanent and resorbablematerials. It should be appreciated that the prosthesis may be formed ofany biologically compatible material, synthetic or natural, suitable forrepairing a tissue or muscle wall defect as would be apparent to one ofskill in the art. The prosthesis may be formed into a patch, plug orcombination patch and plug.

In one embodiment, the prosthesis 30 is formed from a mesh fabric, suchas a sheet of knitted polypropylene monofilament mesh fabric. The sheetmay have a thickness of approximately 0.014 inches and may be knittedfrom polypropylene monofilament having a diameter of approximately0.0042 inches. When implanted, the polypropylene mesh promotes rapidtissue or muscle ingrowth into and around the mesh structure.Alternatively, other surgical materials which are suitable for tissue ormuscle reinforcement and defect correction may be utilized includingBARD MESH (available from C.R. Bard, Inc.), SOFT TISSUE PATCH(microporous ePTFE—available from W.L. Gore & Associates, Inc.);SURGIPRO (available from US Surgical, Inc.); TRELEX (available fromMeadox Medical); PROLENE and MERSILENE (available from Ethicon, Inc.);and other mesh materials (e.g., available from Atrium MedicalCorporation). Biologic materials, including XENMATRIX, COLLAMEND, andALLOMAX (all available from C.R. Bard, Inc.) or COOK SURGISIS (availablefrom Cook Biomedical, Inc.) may also be used. Resorbable materials,including polyglactin (VICRYL—available from Ethicon, Inc.) andpolyglycolic acid (DEXON—available from US Surgical, Inc.), may besuitable for applications involving temporary correction of tissue ormuscle defects. It also is contemplated that the fabric may be formedfrom multifilament yarns and that any suitable method, such as knitting,weaving, braiding, molding and the like, may be employed to form themesh material. It should be appreciated that when the soft tissue repairprosthesis is in the form of a sheet, it may be configured in manyshapes, including, but not limited to flat, concave, and convex, andmay, for example, be in the form of a square, rectangle, circle, orellipse.

Turning now to FIGS. 4-6, another illustrative embodiment of anexpandable device 60 is discussed in greater detail. In this embodiment,the expandable device 60 is lattice shaped and has a plurality ofoutwardly extending arms 62. The expandable device 60 includes an opencenter portion 64 which, as mentioned above, may minimize the size orbulk of the expandable device 60 when the expandable device is rolled orfolded into a reduced profile configuration. As shown in FIGS. 4 and 6,an inflation port 20 allows the expandable device to be inflated orotherwise expanded into a larger profile configuration. In thisparticular embodiment, the inflation port 20 is positioned on an end ofan outwardly extending arm 62 of the expandable device. It should berecognized that the expandable device 62 may be inflated with a gas,such as air, or the expandable device may be filled with a liquid, suchas saline, to reach an expanded profile. Other inflation mediums arecontemplated as should be apparent to one of skill in the art.

As shown in FIGS. 4 and 5, a plurality of loops 70 are secured to theprosthesis 30 and the loops 70 are configured to receive portions of theexpandable device 60, removably connecting the expandable device and theprosthesis. The plurality of loops 70 may be part of a continuum, orintegrated structure, such as a running suture, such that a plurality ofloops 70 are formed with the same length of suture. Similar to theembodiment shown in FIG. 1, the loops 70 extend through the prosthesisand one or more arms 62 of the expandable device 60 extend into theloops 70 to secure the expandable device with the prosthesis. It shouldbe appreciated that in one embodiment, the size of the loops 70 may beadjustable. For example, in one embodiment, the size of the loops 70 maybe adjustable by pulling the loop 70 through the prosthesis. As setforth above, the prosthesis 30 may also include a tether 50, whichfurther may be provided with a loop 52 on one end, to assist inhoisting, locating and/or positioning the soft tissue repair prosthesis.

Once the prosthesis 30 is secured in place, the loops 70 may be cut andremoved from the expandable device/prosthesis interface. It is alsocontemplated that the loops 70 may not need to be cut to detach theexpandable device from the prosthesis, as the loops 40 may be configuredsuch that the arm 62 of the expandable device may slide out of the loopand/or the loops may be configured to be absorbable within the body. Theexpandable device 60 is deflated or otherwise transformed into itsreduced profile configuration and the expandable device may be withdrawnfrom the intra-abdominal space through a trocar.

As mentioned above, an inflation tube 22 may be detachably secured tothe inflation port 20 and the inflation tube 22 may pass through atrocar (not shown) to enable inflation of the expandable device fromoutside of the body. It is also contemplated that a one-way inflationvalve could be used so that once the expandable device is inflated, theinflation tube 22 may be removed from the trocar to free up the trocarfor other instruments. The inflation tube 22 may either be detached fromthe inflation port 20 and removed from the body, or the inflation tubemay be tucked back into the intra-abdominal space and may be removedwith the expandable device.

Furthermore, it is also contemplated that the expandable device may beinflated through an inflation port positioned on the underside of theexpandable device. The inflation port may be grasped to both inflate andmanipulate the expandable device.

FIGS. 7 and 8 illustrate a feature for facilitating connection of one ormore loops with the expandable device. At least one indentation 84 isprovided on the expandable device which receives a loop 40, 70. In theembodiment shown in FIG. 8, the indentations 84 are reduced dimensionedregions of the expandable device and the indentations may be shaped toprevent the loop 40, 70 from undesirably sliding off and detaching fromthe expandable device 80. In one embodiment, the indentations 84 arecircumferential, such that they extend substantially around the arm ofthe expandable device, although an interrupted or partiallycircumferential indentation also is contemplated. In another embodiment,the indentation may be formed by the region between two spaced apartprotrusions on the expandable device.

Once the prosthesis is secured in place over the defect, the loop 40, 70may be cut away from the indentation 84, or the loop 40, 70 may be slidover the indentation 84 to detach the expandable device 80 from theprosthesis 30. It should be appreciated that once the expandable deviceis deflated or otherwise transformed into its reduced profileconfiguration, it may be easier to dislodge the loop from theindentation 84 in the expandable device 80.

As mentioned above, a tether 50 may be secured to the prosthesis toassist in hoisting the prosthesis and the expandable device up to thedefect. In another embodiment, the inflation tube 22 may be used tohoist the prosthesis and the expandable device up to the defect. Inparticular, as shown in FIG. 9, in one embodiment, the inflation tube 22may be secured to an inflation port 20 at approximately the center ofthe prosthesis 30 and the inflation tube 22 may pass through theprosthesis 30. After the prosthesis 30 is inserted into theintra-abdominal space and positioned below the hernia defect, asuture-grasping device (not shown) may be passed through the skin in themiddle of the defect. The inflation tube 22 may be pulled upward withthe grasping device to hoist the prosthesis 30 into position against theabdominal wall. As shown, in one embodiment, the inflation tube 22 issecured to the center of the prosthesis 30 such that the prosthesis 30can more readily be aligned with the center of the hernia defect. Oncethe prosthesis 30 is pulled up and positioned relative to the defect,the prosthesis 30 may be fixated to the margins of the defect usingsutures, fasteners, adhesives or the like in accordance with any of thetechniques known to one of ordinary skill in the art. As shown in theembodiment of FIG. 9, the inflation tube 22 may extend through theprosthesis, and may for example, extend through the mesh of theprosthesis. After inflation, the inflation tube 22 may be disconnectedfrom the inflation port 20 such that the tube 22 can be removed throughthe defect. Thereafter, the expandable device 90 can be detached fromthe prosthesis and deflated, such that the expandable device can beremoved from the body.

FIG. 10 illustrates a bottom view of an expandable device 100 and aprosthesis 30 positioned to cover a defect 110 (shown in dashed lines asit may not be visible through the prosthesis 30). In this embodiment,the expandable device 100 has indicia 102, which, in this particularembodiment is similar to a ruler and may assist in centering theprosthesis 30 relative to the defect 110 and/or measuring the amountthat the prosthesis overlaps the defect. In one embodiment, the indicia102 may include numeric indicia. Although the defect 110 may not bevisible through the prosthesis, the location of the defect may bedetected during a palpation, as the prosthesis 30 may move slightly intothe defect 110, indicating the perimeter of the defect. By adjusting theorientation of the expandable device, the indicia 102 may be used tomeasure the amount of overlap of the prosthesis in one or moredirections. The position of the prosthesis 30 may then be adjustedaccordingly. For example, the indicia 102 may be used for referencing apredetermined location for positioning an edge of a hernia defectrelative to the prosthesis such that the prosthesis overlaps the edge ofthe defect a predetermined distance.

FIG. 7 illustrates another embodiment of an expandable device 80 havingindicia 102. The expandable device 100 may further include indicia suchas, but not limited to markers, arrows, or other indicia to help toorient the expandable device and prosthesis and/or to indicate selectedextraction points on the expandable device where the expandable deviceshould be grasped to remove the expandable device from the body. Theindicia may also be used to show the long axis about which theexpandable device may be rolled to insert into the body. Furthermore,indicia may be used to indicate the locations of the attachmentcomponents. In one embodiment, the indicia is visible, and may forexample include colored markings. In another embodiment, the indicia mayonly be visible with special imaging tools, and in yet anotherembodiment, the indicia may be tactile such that the indicia includes asurface that a user can sense by touch.

Turning now to FIG. 13, another embodiment of an expandable device withindicia is illustrated. For simplification, only a portion of anexpandable device 220 and prosthesis 200 are illustrated, and asdiscussed above, a plurality of attachment components 240 removablyconnect the expandable device 220 with the prosthesis 200. In thisembodiment, the expandable device 220 includes a tab 270 which includesindicia 260. This indicia is for referencing a predetermined locationfor positioning an edge 250 of a hernia defect (shown in dashed lines)relative to the prosthesis 200 such that the prosthesis 200 overlaps theedge 250 of the defect a predetermined distance “d”. In this particularembodiment, the prosthesis 200 is secured with the expandable device 220such that the outer perimeter of the prosthesis is approximately 1 cmaway from the edge of the tab 270. The tab 270 includes indicia 260which includes a plurality of markings that are spaced apartapproximately 1cm. Thus, a user is able to use the indicia 260 such thatthe prosthesis 200 overlaps the edge 250 of the defect a predetermineddistance “d” which is equal to 4 cm in the illustrative embodiment. Inone embodiment, the predetermined distance is between approximately 3cm-approximately 5 cm. However, it should be appreciated that thepredetermined distance may vary based upon the particular defect andprosthesis.

One method of repairing a hernia defect includes inserting a soft tissuerepair prosthesis and an expandable device into an abdominal space wherethe expandable device is removably connected to the soft tissue repairprosthesis and where the expandable device includes indicia referencinga predetermined location, expanding the expandable device, andpositioning the prosthesis around a hernia defect in an abdominal wallby positioning an edge of the hernia defect at the indicia referencingthe predetermined location such that the prosthesis overlaps the edge ofthe defect a predetermined distance.

As illustrated in FIG. 11, in one embodiment, the prosthesis 130 mayinclude at least one slit 132 having a predetermined size configured toreceive a portion of the expandable device 120 to removably connect theprosthesis to the expandable device. In this particular embodiment, theexpandable device 120 has a plurality of arms 122 that are configured toslide into a plurality of slits 132 in the prosthesis. The expandabledevice 120 may be removably connected with the prosthesis 130 when inits reduced or deflated profile configuration, and then, as discussedabove, the expandable device may be expanded or inflated once theprosthesis 130 and expandable device are positioned in the body near thedefect. Once the prosthesis 130 is positioned over the defect, theexpandable device may be detached from the prosthesis by pulling orsliding the arms 122 of the expandable device 120 out from the slits 132in the prosthesis 130. As set forth above, detaching the expandabledevice 120 from the prosthesis 130 may be more easily facilitated afterthe expandable device 120 is deflated or otherwise transformed back intoits reduced profile configuration.

In one embodiment, end portions of the expandable device 130 may remainin a reduced profile when other portions of the expandable device areexpanded or inflated. For example, as shown in the embodimentillustrated in FIG. 12, the end portions of arms 122 may includenon-expandable portions 124. These non-expandable portions 124 may bepassed through the slits 132 in the prosthesis 130 and they may assistin retaining the arms of the expandable device within the slit 132 afterthe expandable device is expanded or inflated. Also, thesenon-expandable portions 124 may help to keep the prosthesis 130 lyingsubstantially flush with the defect and the abdominal wall.

It should be appreciated that the size of the slit 132 is based upon thesize of the portion of the expandable device 10 that would be receivedwithin the slit 132. In one embodiment, the slit has a diameter ofapproximately 2 cm to approximately 10 cm. In another embodiment, theslit has a diameter of at least approximately 5 cm. One of skill in theart would recognize that the slit 132 may be sized to be slightly largerthan the expandable device to accommodate the expandable device 10within the slit 132.

One method of delivering a soft tissue repair prosthesis includesremovably connecting at least one slit of a soft tissue repairprosthesis with an expandable device by inserting a portion of theexpandable device into the at least one slit, and expanding theexpandable device.

The present invention also contemplates other systems for expandingand/or unfurling the prosthesis. Although inflatable expandable devices(either filled with a gas or a liquid) are primarily discussed above,other expandable devices that don't rely on inflation are contemplated.For example, and without limitation, also contemplated are an expandabledevice that includes telescoping portions and/or umbrella-like spokes,an expandable device including shape memory material, and an expandabledevice that resiliently expands into an enlarged configuration.

It should be appreciated that various embodiments of the presentinvention may be formed with one or more of the above-describedfeatures. The above aspects and features of the invention may beemployed in any suitable combination as the present invention is notlimited in this respect. It should also be appreciated that the drawingsillustrate various components and features which may be incorporatedinto various embodiments of the present invention. For simplification,some of the drawings may illustrate more than one optional feature orcomponent. However, the present invention is not limited to the specificembodiments disclosed in the drawings. It should be recognized that thepresent invention encompasses embodiments which may include only aportion of the components illustrated in any one drawing figure, and/ormay also encompass embodiments combining components illustrated inmultiple different drawing figures.

It should be understood that the foregoing description of variousembodiments of the invention are intended merely to be illustrativethereof and that other embodiments, modifications, and equivalents ofthe invention are within the scope of the invention recited in theclaims appended hereto.

1. A hernia repair device, comprising: a soft tissue repair prosthesis;at least one loop extending from the prosthesis, wherein the at leastone loop has a predetermined size configured to receive a portion of anexpandable device to removably connect the prosthesis with theexpandable device.
 2. The hernia repair device of claim 1, wherein theat least one loop includes a plurality of loops, wherein the pluralityof loops each have a predetermined size configured to receive a portionof the expandable device to removably connect the prosthesis with theexpandable device to position the prosthesis adjacent the hernia defect.3.-14. (canceled)
 15. A hernia repair device, comprising: a soft tissuerepair prosthesis having at least one slit therethrough, wherein the atleast one slit has a predetermined size configured to receive a portionof an expandable device to removably connect the prosthesis with theexpandable device. 16.-23. (canceled)
 24. A hernia repair device,comprising: a soft tissue repair prosthesis having a first side and asecond side; at least one attachment component coupled to the prosthesisand extending outwardly from the first side of the prosthesis, theattachment component configured to receive a portion of an expandabledevice to removably connect the prosthesis with the expandable device;and a tether coupled to the prosthesis and extending outwardly from thesecond side of the prosthesis, wherein manipulation of the tether allowshoisting, locating and/or positioning of the soft tissue repairprosthesis.
 25. The hernia repair device of claim 24, wherein the tetheris coupled to the prosthesis at approximately the center of theprosthesis.
 26. The hernia repair device of claim 24, wherein the tetheris formed from suture material.
 27. The hernia repair device of claim24, wherein one end of the tether includes a loop configured to graspthe tether.
 28. The hernia repair device of claim 24, wherein the atleast one attachment component is at least one loop extending from theprosthesis, wherein the at least one loop has a predetermined sizeconfigured to receive a portion of an expandable device to removablyconnect the prosthesis with the expandable device to position theprosthesis adjacent the hernia defect.
 29. The hernia repair device ofclaim 24, wherein the at least one attachment component includes aplurality of loops, wherein the plurality of loops each have apredetermined size configured to receive a portion of the expandabledevice to removably connect the prosthesis with the expandable device toposition the prosthesis adjacent the hernia defect.
 30. The herniarepair device of claim 24, further comprising an expandable device thatwhen expanded, is configured to position the prosthesis adjacent thehernia defect.
 31. The hernia repair device of claim 30, wherein theexpandable device is inflatable with air.
 32. The hernia repair deviceof claim 24, wherein the soft tissue repair prosthesis is formed from amesh fabric.
 33. The hernia repair device of claim 24, wherein the softtissue repair prosthesis is formed into a sheet.
 34. The hernia repairdevice of claim 24, wherein the soft tissue repair prosthesis is formedinto a plug.
 35. A hernia repair device, comprising: an expandabledevice configured to be removably connected with a soft tissue repairprosthesis; wherein the expandable device includes indicia forreferencing a predetermined location for positioning an edge of a herniadefect relative to the prosthesis such that the prosthesis overlaps theedge of the defect a predetermined distance. 36.-45. (canceled)
 46. Amethod of delivering a soft tissue repair prosthesis, comprising:removably connecting at least one loop of a soft tissue repairprosthesis with a portion of an expandable device; and expanding theexpandable device. 47.-48. (canceled)
 49. A method of delivering a softtissue repair prosthesis, comprising: removably connecting at least oneslit of a soft tissue repair prosthesis with an expandable device byinserting a portion of the expandable device into the at least one slit;and expanding the expandable device. 50.-51. (canceled)
 52. A method ofrepairing a hernia defect, comprising: removably connecting at least oneattachment component coupled to a first side of a soft tissue repairprosthesis with an expandable device to removably connect the softtissue repair prosthesis with the expandable device; inserting theprosthesis and the expandable device into an abdominal space; expandingthe expandable device; and manipulating a tether coupled to a secondside of the soft tissue repair prosthesis to hoist, locate or positionthe soft tissue repair prosthesis.
 53. The method of claim 52, furthercomprising: securing the prosthesis to the abdominal wall; and detachingthe prosthesis and the at least one attachment component.
 54. A methodof repairing a hernia defect, comprising: inserting a soft tissue repairprosthesis and an expandable device into an abdominal space where theexpandable device is removably connected to the soft tissue repairprosthesis and wherein the expandable device includes indiciareferencing a predetermined location; expanding the expandable device;and positioning the prosthesis around a hernia defect in an abdominalwall by positioning an edge of the hernia defect at the indiciareferencing the predetermined location such that the prosthesis overlapsthe edge of the defect a predetermined distance.
 55. (canceled)